Medication info
Cefuroxime Axetil Tablets (Cefuroxime Axetil)

Cefuroxime Axetil Tablets (Cefuroxime Axetil)

Prescription medicationTabletOral
Ingredient · strength
Cefuroxime Axetil›300.72mg / 1 tablet
Manufacturer / importer
Iyeon Pharmaceutical Co., Ltd.
Appearance
White to off-white oblong film-coated tablets
Packaging
100 tablets (10 tablets/PTP*10)
Approval status
Active

MFDS item code 202001094 · Approved 2020.02.18 · Insurance code 658604060

Summary

Main use
Treatment of respiratory and genitourinary infections (including gonorrhea), skin and soft-tissue infections, and early Lyme disease
Who takes it
Adults · Children
Adult dose
For optimal absorption, take after meals. 1. Adults and children 12 years of age and older 1) Most infections Administer 250mg twice daily. 2) Severe lower respiratory tract infections, pneumonia, severe infections, or suspected infections caused by organisms with low susceptibility Administer 500mg twice daily. 3) Urinary tract infections Administer 250mg twice daily. 4) Uncomplicated gonorrhea Administer 1g as a single dose. 5) Lyme disease Administer 500mg twice daily for 14 days (10~21 days). For the treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), this medicine should be administered for 7~10 days. 3. Patients with renal impairment Cefuroxime is primarily eliminated by the kidneys. To compensate for delayed elimination in patients with significantly impaired renal function, dose reduction of cefuroxime as indicated below is recommended. Creatinine clearance ≥ 30 mL/min/1.73m2, T1/2 (hours) 1.4 - 2.4: No dose adjustment required (standard dose: 125mg-500mg twice daily) Creatinine clearance 10 - 29 mL/min/1.73m2, T1/2 (hours) 4.6: Administer the standard single dose every 24 hours Creatinine clearance < 10 mL/min/1.73m2, T1/2 (hours) 16.8: Administer the standard single dose every 48 hours Patients on hemodialysis, T1/2 (hours) 2 - 4: Administer an additional standard single dose at the end of each dialysis session
Child dose
2. Infants and children under 12 years of age 1) Most infections Administer 125mg twice daily. For otitis media in children 2 years of age and older and for severe infections, administer 250mg twice daily. 2) Lyme disease Administer 250mg twice daily for 14 days (10~21 days). There is insufficient experience with use in infants under 3 months of age. This medicine should not be divided and is therefore not suitable for treating patients, such as young infants and children, who cannot swallow tablets.

Ingredients

Manufacturer
Iyeon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory and genitourinary infections (including gonorrhea), skin and soft-tissue infections, and early Lyme disease

  • Otitis media
  • sinusitis
  • tonsillitis
  • pharyngitis
  • acute bronchitis
  • chronic bronchitis
  • pneumonia
  • pyelonephritis
  • cystitis
  • urethritis
  • furunculosis
  • pyoderma
View approved original text

Cefuroxime is a broad-spectrum antibiotic effective against a variety of bacteria and is very stable against beta-lactamase, making it effective against Ampicillin or Amoxicillin-resistant strains. It is used to treat upper respiratory infections such as otitis media, sinusitis, tonsillitis, and pharyngitis, as well as lower respiratory infections such as acute and chronic bronchitis and pneumonia. It is also effective against urogenital infections such as pyelonephritis, cystitis, and urethritis, as well as skin and soft tissue infections such as furunculosis, pyoderma, and impetigo. It is used in the treatment of acute uncomplicated urethritis and cervicitis caused by gonorrhea, and assists in the treatment of early Lyme disease. Thus, cefuroxime is widely used to treat various infections, aiding in the recovery of patients' health.

How to take

Adult dose

For optimal absorption, take after meals. 1. Adults and children 12 years of age and older 1) Most infections Administer 250mg twice daily. 2) Severe lower respiratory tract infections, pneumonia, severe infections, or suspected infections caused by organisms with low susceptibility Administer 500mg twice daily. 3) Urinary tract infections Administer 250mg twice daily. 4) Uncomplicated gonorrhea Administer 1g as a single dose. 5) Lyme disease Administer 500mg twice daily for 14 days (10~21 days). For the treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), this medicine should be administered for 7~10 days. 3. Patients with renal impairment Cefuroxime is primarily eliminated by the kidneys. To compensate for delayed elimination in patients with significantly impaired renal function, dose reduction of cefuroxime as indicated below is recommended. Creatinine clearance ≥ 30 mL/min/1.73m2, T1/2 (hours) 1.4 - 2.4: No dose adjustment required (standard dose: 125mg-500mg twice daily) Creatinine clearance 10 - 29 mL/min/1.73m2, T1/2 (hours) 4.6: Administer the standard single dose every 24 hours Creatinine clearance < 10 mL/min/1.73m2, T1/2 (hours) 16.8: Administer the standard single dose every 48 hours Patients on hemodialysis, T1/2 (hours) 2 - 4: Administer an additional standard single dose at the end of each dialysis session

Child dose

2. Infants and children under 12 years of age 1) Most infections Administer 125mg twice daily. For otitis media in children 2 years of age and older and for severe infections, administer 250mg twice daily. 2) Lyme disease Administer 250mg twice daily for 14 days (10~21 days). There is insufficient experience with use in infants under 3 months of age. This medicine should not be divided and is therefore not suitable for treating patients, such as young infants and children, who cannot swallow tablets.

Precautions

This medication should not be used in patients with hypersensitivity to cephalosporin antibiotics. Caution is advised when administering to patients with a history of allergy to penicillin or other beta-lactam antibiotics, asthma or skin allergy symptoms, severely impaired kidney function, patients who have difficulty swallowing oral medications, elderly patients, and those in poor general health. While using this medication, mild and transient side effects may occur, but serious skin reactions, blood abnormalities, or liver dysfunction may rarely arise, so symptoms should be closely monitored. Common side effects include headache, dizziness, diarrhea, nausea, and abdominal pain, and in severe cases, seizures or psychiatric symptoms may occur, necessitating caution. Due to the use of antibiotics, there is a risk of excessive growth of Candida species in the gut or serious gastrointestinal diseases such as pseudomembranous colitis, so if diarrhea or abdominal pain persists, immediate consultation with a healthcare professional is required. This medication may interact with other drugs, particularly diuretics, aminoglycoside antibiotics, probenecid, and antacids, so caution is warranted when used together. Pregnant or nursing women should only take this medication if the benefits outweigh the risks, and care should be taken when using it during breastfeeding as it may affect the infant. Safety has not been established for pediatric patients, particularly infants under 3 months of age, and crushing the tablet can result in a very bitter taste, so a dry syrup formulation is recommended for children. Elderly patients may have reduced physiological function, increasing the risk of side effects, so dosages and intervals should be carefully adjusted and monitored, with vigilance for bleeding risks due to vitamin K deficiency. This medication may affect blood tests or urine tests; therefore, inform healthcare staff of its use during testing, and overdose may result in seizures requiring immediate treatment. Store in a safe place out of reach of children, in its original container, to prevent quality degradation or misuse.

Side effects

  • Candida overgrowth
  • eosinophilia
  • positive Coombs test
  • thrombocytopenia
  • leukopenia
  • granulocytopenia
  • erythrocytopenia
  • hemoglobin decrease
  • hematocrit decrease
  • hemolytic anemia
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  • skin rash
  • urticaria
  • itching
  • drug fever
  • serum sickness
  • anaphylaxis
  • facial swelling
  • lymphadenopathy
  • arthralgia
  • headache
  • dizziness
  • diarrhea
  • nausea
  • abdominal pain
  • vomiting
  • dyspepsia
  • constipation
  • loss of appetite
  • membranous colitis
  • abdominal distension
  • fever
  • cough
  • dyspnea
  • chest X-ray abnormalities
  • interstitial pneumonia
  • eosinophilic pulmonary infiltration
  • transient increase in liver enzymes
  • jaundice
  • hepatitis
  • increased BUN
  • acute renal failure
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • symptoms of vitamin K deficiency
  • symptoms of vitamin B complex deficiency
  • pain
  • perioral sensory disturbance
  • tingling of the tongue
  • oropharyngeal abnormalities
  • xerostomia
  • palpitations
  • eczema
  • DRESS syndrome
  • shock symptoms
  • malaise
  • oral dysgeusia
  • wheezing
  • bowel urgency
  • tinnitus
  • sweating
  • seizures
  • anxiety
  • agitation
  • mental confusion
  • hallucinations
  • Cushing's syndrome

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, in a cool place below 30 degrees Celsius. Doing so will help maintain its effectiveness and prevent degradation.

Appearance and packaging

Appearance

White to off-white oblong film-coated tablets

Package unit

100 tablets (10 tablets/PTP*10)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.